DRUG
Maridebart Cafraglutide
Maridebart cafraglutide will be administered SC.
Status
Completed
Phase
Phase 1
Enrollment
348
Locations
4
Results
Not posted
Publications
0
Study summary
The main objective of this trial is to evaluate the pharmacokinetics (PK) of maridebart cafraglutide administered as a single dose using two different SC presentations in participants living with overweight or obesity.
Interventions
DRUG
Maridebart cafraglutide will be administered SC.
Timeline
First posted
Nov 10, 2025
Study start
Oct 10, 2025
Primary completion
May 28, 2026
Study completion
May 28, 2026
Results posted
Not reported
Registry updated
Jun 17, 2026
Outcomes
Area Under the Plasma Concentration Time Curve from Time Zero to Infinity (AUCinf) of Maridebart Cafraglutide
Time frame · Up to Day 120
Area Under the Plasma Concentration Time Curve from Time Zero to Time of Last Quantifiable Concentration (AUClast) of Maridebart Cafraglutide
Time frame · Up to Day 120
Maximum Observed Plasma Concentration (Cmax) of Maridebart Cafraglutide
Time frame · Up to Day 120
Number of Participants with Treatment-emergent Adverse Events
Time frame · Up to Day 120
Number of Participants with Serious Adverse Events
Time frame · Up to Day 120
Number of Participants with Anti-maridebart Cafraglutide Antibody Formation
Time frame · Up to Day 120
Eligibility
Inclusion Criteria 1. Male or female, of any race, between 18 and 60 years of age, inclusive. a. Females must not be pregnant or lactating. 2. Body mass index between ≥25.0 and \<40.0 kg/m\^2. Exclusion Criteria 1. History or evidence, at screening or check-in, of clinically significant disorder, condition, or disease not otherwise excluded that, in the opinion of the investigator (or designee), would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion. 2. History of or active diabetes (regardless of type, with the exception of a history of gestational diabetes) or hemoglobin A1C ≥6.5% (≥48 mmol/mol). 3. History or evidence of endocrine disorder (eg, Cushing's Syndrome) that can cause obesity. 4. History of acute or chronic pancreatitis within 1 year prior to check-in, or elevation in serum lipase/amylase (\>2 x the upper limit of normal) at screening or a fasting serum triglyceride level of \>500 mg/dL at screening. 5. Malignancy, except nonmelanoma skin cancers or cervical or breast ductal carcinoma in situ, within the last 5 years. 6. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2. 7. History or current signs or symptoms of cardiovascular disease (aside from controlled hypertension and controlled dyslipidemia), including but not limited to myocardial infarction, congenital heart disease, valvular heart disease, coronary revascularization, or angina. 8. History or evidence of clinically significant arrhythmia at screening, including any clinically significant findings on the ECG taken at screening or check-in. 9. History of hypersensitivity, intolerance, or allergy to maridebart cafraglutide or related/similar compounds or their ingredients. 10. Estimated glomerular filtration rate ≤60 mL/min/1.73 m\^2, as calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) equation at screening or check-in. 11. Use of any over-the-counter or prescription medications within 30 days or 5 half-lives (whichever is longer) before check-in. 12. Current use or prior use of any glucagon-like peptide-1 receptor (GLP-1R) agonist, or glucose-dependent insulinotropic polypeptide receptor (GIPR) agonist or antagonist within the past 3 months prior to check-in. 13. Current or prior use of all herbal medicines (eg, St. John's wort), vitamins, and supplements consumed by the participant within the 30 days prior to enrollment, unless deemed acceptable by the investigator (or designee) and in consultation with the medical monitor, as appropriate. 14. Participant has received a dose of an investigational drug within the past 30 days or 5 half-lives, whichever is longer, prior to check-in. 15. Have previously completed or withdrawn from this study or any other study investigating maridebart cafraglutide or have previously received the investigational product.
Study locations
United States. Showing up to 24 locations stored in the fast local snapshot.
Anaheim Clinical Trials
Anaheim, California, United States
Fortrea Clinical Research Unit - Daytona Beach
Daytona Beach, Florida, United States
Fortrea Clinical Research Unit - Dallas
Dallas, Texas, United States
Fortrea Clinical Research Unit Inc. - Madison
Madison, Wisconsin, United States
Publications
No PMID-linked publications were present in this registry snapshot.
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